OtoLase™ Curved Tip Package

GUDID 07290109142791

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system

• Primary Device ID: 07290109142791
• NIH Device Record Key: 1a208d97-0b10-420f-a27e-0dab53bffebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OtoLase™ Curved Tip Package
• Version Model Number: OtoLase™ Curved Tip Package
• Company DUNS: 600166524
• Company Name: LUMENIS LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Dimensions

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109142791 [Primary]
GS1	17290109142798 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100384

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-05

Devices Manufactured by LUMENIS LTD.

• 07290118853701 - Lumenis Pulse 60H, 60Hz: 2023-12-18
• 07290109144924 - Stellar SapphireCool LG 6mm: 2023-08-16
• 07290109144931 - Stellar SapphireCool LG 15x35: 2023-08-16
• 07290109144948 - Stellar SapphireCool LG 8x15: 2023-08-16
• 07290109146676 - SurgiTouch Scanner: 2022-09-30
• 07290109146133 - UltraPulse® DUO: 2022-09-28 UltraPulse DUO
• 07290109147055 - VersaPulse PowerSuite 80/100W: 2022-09-27
• 07290109147062 - VersaPulse PowerSuite 80/100W: 2022-09-27